January 17, 2006

Lundbeck launches new schizophrenia drug in Europe

H. Lundbeck A/S today announced that Serdolect® (sertindole) is now available in the first country in Europe – Estonia. This is the first launch of Serdolect®, which received marketing approval for the treatment of schizophrenia from the European Commission on 20 December 2005. Serdolect® is expected to be launched in a number of countries among others the Scandinavian countries and in Germany in the first half of 2006 and in more than 15 other countries during 2006 and 2007.

Serdolect was granted marketing approval for the treatment of schizophrenia by the European Commission on December 20, 2005.

About Serdolect®
Serdolect® is an effective antipsychotic drug for the treatment of schizophrenia without sedative effect and with placebo level extra pyramidal symptoms. Serdolect® has an inhibitory effect on central dopamine D2 and serotonin 5HT2 receptors as well as on alpha-adrenergic receptors.

Since the 1990s, the efficacy and safety of using Serdolect® has been evaluated in numerous studies including more than 17,000 patients.

Since CHMP’s (Committee for Medicinal Products for Human Use, under EMEA) temporary suspension of the marketing authorisation for Serdolect® in 1998, Lundbeck has included an additional 5,000 patients in a study confirming that Serdolect® can be prescribed safely.

Serdolect® derives from Lundbeck’s in-house research, and the company holds the global rights.

Source: Lundbeck, AS


Are there any plans to resubmit for approval of this drug in the USA? My son and many others participated in the trials here and really liked this drug.

Posted by: R.W.Porter at January 25, 2006 07:23 AM

My sister was on trial for this drug in India for about a month but withdrew as she developed QT prolongation.

Posted by: manoj at February 5, 2006 10:13 AM

i would like to know of any new drugs for schizophrenia that have known to be able to help my son suffering from schizophrenia since he was 18 years old.

Posted by: faye bolden at February 9, 2006 08:13 AM

I live in Estonia.I have schizophrenia since i was
18, now i am 23, i had on many
atypically drugs,last was Zyprexa,but it had on me very bad side affect- the weight gain,(i think all day about wood, but good is that i have full time work,that that time i cannot eat that much) and my doctor offer me this new dug Serdolect, lets see
if it is good on me.

Posted by: roger at April 12, 2006 11:07 PM

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